Kornimate/medical-research-clean huggingface dataset:
identification of high-risk patients at admission to an emergency department by non-invasive hemodynamics

Conditions: Emergency Department Triage; Non-invasive Hemodynamic

Summary: the goal of this study is to evaluate the prognostic values of non-invasive hemodynamic parameteres in relation to 30-day mortality and/or acute deterioration in patients who are admitted acutely to the department of emergency medicine or cardiology.

background identification of critically ill and high-risk patients at hospital admission is a major triage task in the emergency department. rapid identification and treatment of such patients improves survival, reduces complications during admission, duration of hospitalization and the costs of treatment. reduced heart rate variability (hrv), a marker of autonomic imbalance towards sympathetic dominance, has been shown in several studies to be associated with a poor prognosis in patient groups like myocardial infarction, heart failure, ischemic heart disease, and others. besides hrv other hemodynamic variables like cardiac stroke volume, cardiac output and peripheral resistance will potentially improve diagnosis of critically ill patients by providing better prognostic value. aims \& objectives to develop and validate a prognostic model (based on selected variables derived from finapres measurements, hrv, co, and tp) for 30-day mortality and/or acute deterioration in patients who are admitted acutely to the department of emergency medicine or cardiology, university hospitals of bispebjerg \& frederiksberg methods \& materials the study is designed as an observational prospective cohort study. the aim is to enroll 1635 patients in total. during a period of 6 to 9 months all patients admitted to the acute medical/emergency department at bispebjerg hospital, copenhagen, denmark adn who fulfills inclusion criterias will be examined with a 10 minutes examination with the finapres nova device. patients admitted to the departments of medicine/emergency medicine / cardiology at bispebjerg hospital will also be included. expected outcomes and perspectives several scoring algorithms have been used in the emergency departments to facilitate early recognition of patients with high risk of serious outcomes. there is need to develop better clinical tools to be used in the emergency departments. the investigators expect to outperform current triage methods by including hrv and hemodynamic parameters.

Eligibility criteria:
inclusion criteria: * age \> 18 years * admittance with acute illness at the department of medicine/emergency medicine / cardiology at bispebjerg hospital * able to give informed consent exclusion criteria: * terminal disease like advanced cancer or advanced organ failure with a life expectancy of less then three months. * candidate for immediate intensive care therapy * refuse or unable to give consent

Keywords: emergency department risk prediction non-invasive hemodynamic heart rate variability
a prospective cohort study of for surgical treatment of irreducible atlantoaxial dislocation

Conditions: Atlantoaxial Dislocation

Summary: the management of irreducible atlantoaxial dislocation associated is challenging. direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. in 2020, we modified this technique and proposed a posterior intra-articular distraction technique. the intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. however, its superiority has not been proven. therefore, we design a prospective study to compare the reduction rate and fusion rate of different strategies.


Eligibility criteria:
inclusion criteria: ct indicated atlantoaxial dislocation agree with the operation plan agree to be followed up exclusion criteria: the pathology is traumatic or ra underwent operations in occipital-cervical region before with mortal diseases without ability to sign papers
incb040093 and incb040093 combined with itacitinib (incb039110) in relapsed/refractory hodgkin lymphoma

Conditions: Refractory Hodgkin Lymphoma; Recurrent Adult Hodgkin's Lymphoma

Summary: a phase 2, open-label study to evaluate the safety and efficacy of incb040093 as monotherapy and as combination therapy with itacitinib (incb039110) in subjects with relapsed or refractory hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * men and women, aged 18 years or older * histologically confirmed diagnosis of classical hl * must be relapsed or refractory after autologous stem cell transplant (asct) and/or 2 or more prior chemotherapy regimens * must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin * eastern cooperative oncology group (ecog) 0 to 2 exclusion criteria: * laboratory parameters not within the protocol-defined range * received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug. * received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug except steroids at ≤ 10 mg prednisone daily (or equivalent). * has any unresolved toxicity ≥ grade 2 from previous anticancer therapy * received autologous stem cell transplant within 28 days or allogeneic transplant within 3 months prior to first dose of study drug * history of lymphoma involving the central nervous system * evidence of active or prior hepatitis infection.

Keywords: refractory hodgkin lymphoma relapsed hodgkin lymphoma
raclopride-pet/mrt

Conditions: Diabetes Mellitus, Type 2

Summary: cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. the aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. therefore, characteristics of cerebral dopamine receptors before and after administration of nasal insulin vs. placebo shall be analyzed in a randomized way. moreover, the investigators plan to examine the insulin action on cortical and subcortical activation in humans and the interaction of dopamine metabolism with \[11c\]-raclopride-pet/mri. by performing fmri measurements, insulin sensitivity of the central nervous system can be investigated simultaneously. recruiting is planed as a two-step process.first 12 normal-weight (bmi 20-25 kg/m²) men should be examined. if first results show a insulin-dependent effect on the availability of dopamine receptors in the human brain, recruitment of 12 overweight men will get started.


Eligibility criteria:
inclusion criteria: * understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. * intake of any medication * hba1c \<6% * bmi 20-25 kg/m² * clinical routine blood parameters within the normal ranges * all participants must agree to get informed of unexpected detected, clinical relevant findings. exclusion criteria: * acute diseases such as infections (e.g.) * any relevant cardiovascular disease * any surgery within the last three months * any neurologic or psychiatric disease * known allergies * hb \< 13 g/dl * presence of any contraindication for the conduct of an mri investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc. * claustrophobia

Keywords: diabetes mellitus, type 2 cerebral insulin resistance insulin action in the human brain dopamine signalling
evaluating the healthy families prep program for women at risk for hiv

Conditions: HIV; Pregnancy; Pre-Exposure Prophylaxis of HIV Infection

Summary: study investigators developed and piloted a counselling intervention, healthy families-prep, that supports women to use hiv prevention strategies while trying for and during pregnancy. they will now adapt the intervention to community clinics and postpartum women and test the intervention. the goal is to reduce hiv incidence among women and children.

women in uganda who are planning for pregnancy, pregnant, or postpartum and have a partner living with hiv are vulnerable to acquiring hiv. adapting this intervention to community clinics and testing effectiveness aligns with global and ugandan ministry of health goals to reduce hiv incidence among women of reproductive age and eliminate perinatal transmission. additionally, costing analyses will be conducted to determine the cost of implementing hf-prep from both payer and societal perspectives. this work will inform future intervention implementation.

Eligibility criteria:
inclusion criteria: * age ≥18 years and ≤45 years * willing and able to participate in the informed consent process * hiv-uninfected by self-report, but have indications for hiv prevention strategies, such as having a partner living with hiv or who they think may be living with hiv * reporting pregnancy in the past 2 years, and/or desire to have a child in the next year, and/or have a partner who desires to a child in the next year * fluent in english or local language * living within 60km of a healthcare center included in the trial * hiv negative (onsite rapid testing) exclusion criteria: * not reporting pregnancy in the past 2 years * does not report personal or partner desire to have a child in the next year * not willing to provide informed consent * not able to communicate in english or local language * does not report pregnancy in the past 2 years and/or does not report personal or partner desire to have a child in the next year * not able to communicate in english or local language * living beyond 60km of the trial healthcare center * hiv-positive (onsite rapid testing)

Keywords: hiv pregnancy pre-exposure prophylaxis
a phase ii trial of mb-6 plus folfox4 for metastatic colorectal cancer (fda ind 103675)

Conditions: Colorectal Cancer

Summary: this is a randomized, double-blind, parallel group, placebo-controlled study evaluate the preliminary efficacy and safety of mb-6 (320 mg/capsule, 6 capsules tid) versus placebo in addition to standard chemotherapy in the treatment of patients with metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis; 2. at least one measurable lesion either by computer tomography (ct) scan or magnetic resonance imaging (mri); 3. aged 20 years old or above; 4. eastern cooperative oncology group (ecog) performance status \< 2; 5. adequate bone marrow reserve (hemoglobin \> 9 g/dl, absolute neutrophil count \> 1.5 x 109/l, platelets \> 100 x 109/l); 6. adequate renal and hepatic functions: total bilirubin \< 1.25 x upper normal limit, creatinine \< 1.25 x upper normal limit, alanine aminotransferase (alt) or aspartate aminotransferase (ast) \< 2.5 x upper normal limit; 7. patients willing to participate in the trial and giving written informed consent. exclusion criteria: 1. pregnant or lactating patients; 2. patients (male or female) with reproductive potential not using adequate contraceptive measures; 3. patients with evidence of central nervous system metastasis; 4. subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents 5. current history of chronic diarrhea; 6. other serious illness or medical conditions (e.g.: history of angina, myocardial infarction); 7. history of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 8. concurrent treatment with any other anticancer therapy; 9. patients with congestive heart failure (new york heart association functional classification iii or iv), epilepsy, or other significant medical conditions as judged by the investigator; 10. patients treated with another investigational drug within 4 weeks of entry into this study.

Keywords: mb-6 folfox4 metastatic colorectal cancer
randomized, crossover safety and pharmacokinetics study of pt010

Conditions: COPD

Summary: safety and pharmacokinetics of two doses of pt010 in healthy adult subjects of japanese descent following a single dose and after chronic dosing for 7 days.

this is a phase i, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and pk of two doses of pt010 in healthy adult subjects of japanese descent. safety and pk will be assessed following a single dose and during twice-daily (bid) chronic dosing for 7 days.

Eligibility criteria:
inclusion criteria: * informed consent form (icf) prior to any study related procedures * male and female subjects first generation japanese subjects 18 to 55 years, inclusive * body weight ≥50 kg (110 lbs) at the screening visit and body mass index between 18.5 and 32 kg/m2, inclusive * good general health * medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential * clinical labs within normal ranges or determined to be not clinically significant by the investigator exclusion criteria: * pregnancy, nursing female subjects, or subjects trying to conceive * clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study * history of ecg abnormalities * cancer not in complete remission for at least 5 years * clinically significant, symptomatic prostatic hypertrophy * male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening * clinically significant bladder neck obstruction or urinary retention * inadequately treated glaucoma * history of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study * subjects with pre-existing anemia and/or iron deficiency

Keywords: healthy volunteers
cardiovascular effects of a soccer match in viewers with with coronary artery disease

Conditions: Coronary Artery Disease

Summary: watching football matches could cause increased blood pressure and heart rate induced by catecholamines and thus increase the incidence of cardiovascular events. however, no studies have evaluated the responses of blood pressure and heart rate in soccer spectators. this study evaluates the hemodynamic response in brazilian soccer fans suffering from coronary artery disease during a dispute over a game of your favorite team.


Eligibility criteria:
inclusion criteria: * coronary artery disease; * avai or figueirense (brazilian soccer teams) fans exclusion criteria: * acute coronary syndrome in less than 7 days
a study of tdcs for unilateral neglect in stroke patients

Conditions: Stroke

Summary: the primary objective of this study is to confirm and compare the effect of methods of transcranial direct current stimulation(tdcs) in the unilateral neglect of stroke patients

total 105 patients were recruited and randomized to receive either real or sham-tdcs. real experimental groups were divided into two types; pre-tdcs group and simultaneous tdcs group. two groups are again divided into three groups; dual stimulation group, unilateral stimulation group and sham control group, respectively. in pre-tdcs group, total a sessions of the tdcs stimulation was done for each three subgroups and visual inattention training was followed after that. in simultaneous tdcs group, tdcs and visual inattention training was done simultaneously. for each subgroups, tdcs was attached at following locations; unilateral cathodal tdcs on unaffected ppc(postparietal cortex), p3 , dual cathodal tdcs on p3 and anodal tdcs on affected ppc, p4. the patients were initially evaluated at baseline, immediately, 60min, 120min, 24 hrs after the training session.

Eligibility criteria:
inclusion criteria * subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis * subjects who have cortical or subcortical brain lesion * subjects ages older than 18years old * subjects who have 19 of k-mmse score * subjects who has unilateral neglect with bit-c less than 129 * subjects who understand the purpose of the study and acquired the consent of the patient or caregiver * subjects who had no effect from brain stimulation or electrical stimulation therapy * subjects whose dominant side are confirm by edinburgh handedness inventory exclusion criteria * subjects who have pre-existing and active major neurological disease * subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia * subjects who have brain lesion except cortex or subcortex area * subjects who have any metal component after brain surgery, low threshold to pain, history of seizure * subjects who is estimated as not appropriate for the study by the investigators
modified tap (transverse abdominis plane) block in colorectal surgery

Conditions: Pain, Postoperative

Summary: single blind, randomized controlled study to see if tap block with exparel provides better pain relief than tap block with bupivicaine. differences in pain scale, length of stay, and total narcotic use in the hospital will be evaluated.

subjects recruited into the study will undergo surgery as scheduled. during the procedure they will receive a tap block with one of the pain medications. tap block in the experimental arm will be performed with 20 ml (266mg) of liposomal bupivacaine with 25 ml (5 mg/ml) of bupivacaine diluted in 55 ml of normal saline. the control arm will have a tap block performed with 30 ml (5mg/ml) of bupivacaine diluted in 70 ml of normal saline. these doses are consistent with prior studies of tap block with liposomal bupivacaine. subjects will be monitored for pain as per standard of care and will be given pain medication as needed. subject recruitment and screening patients will be recruited from the ochsner colorectal surgery clinic at the time of a preoperative visit. study procedures screening \& baseline visit after obtaining informed consent the subjects relevant medical and surgical history will be documented. demographics and vitals will be documented. current use of pain medication will be recorded. a physical exam will be performed. day of surgery routine vital signs will be obtained preoperatively. during the operation subject will receive a tap block containing their randomized local injection mixture as described above. following surgery the subject will recover the pacu and pain medication will be provided on demand. initial postoperative vital signs and pain scores will be obtained at this time. post-operative course postoperatively subject will have regularly scheduled vital signs and pain scores obtained, and recorded for study use. narcotic and non-narcotic pain medication will be provided on demand; dosages will be recorded for study use. subjects will be followed until they are discharged at which time study participation will be complete.

Eligibility criteria:
inclusion criteria: * patients age 18-75 years undergoing planned laparoscopic colon or rectal resection exclusion criteria: 1. patients younger than 18 or older than 75 years old 2. pregnant women 3. patients who have taken steroids or other immunomodulators within the last 6 months 4. patients on home narcotics 5. patients allergic to exparel or bupivacaine
home monitoring to predict exacerbation in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the study aims to establish if it is possible for people with cystic fibrosis to monitor a number of parameters on a daily basis at home which might predict respiratory infections before they have symptoms and which might also predict treatment failures before this is obvious with conventional measures.

participants will collect the following clinical information daily: pulse rate and oxygen saturations, wellness and cough scores, spirometry measurements, physical activity, temperature, weight and sleep quantity and quality. the patients will also collect daily sputum samples. data will be collected via bluetooth-enabled devices and transmitted via a smart-phone to a secure national health service approved web-based site to be analyzed. the information obtained will allow the investigators to develop a software program that will identify signals that can predict the onset of a chest infection before symptoms develop. the investigators will also measure specific substances in sputum to identify changes before, during and after chest infections. the investigators hope this additional information will enable them to more accurately predict the onset of chest infections in cystic fibrosis. the results of this study will determine if it is possible to develop a simple sputum test for patients to use at home in combination with other home-based assessments of well-being to provide an early warning system of a chest infection before patients feel unwell.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cystic fibrosis based on genetic testing and/or sweat chloride. 2. age ≥ 18 years of age. 3. a history of at least 1 acute pulmonary exacerbation in the past 12 months. 4. able to provide written informed consent. 5. willing and able to produce daily sputum samples. 6. willing and able to provide daily telemetric measure of several physiological parameters. exclusion criteria: 1. patients unable to provide written informed consent 2. patients unable to produce daily sputum samples 3. less than 1 infective pulmonary exacerbation in 12 months 4. lung transplant recipients
development of gourmet healthy cooking workshop for cancer patients

Conditions: Breast Cancer

Summary: subjects that participate in the practical workshop will improve their metabolic indexes, control their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions

participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. the workshop will consist of 6 lessons with the following lessons: introduction, caloric density of food, fats, vegetable and fruits, whole grains and legumes, healthy desserts . all the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours "hands on" session under supervision of a medical chef. the study population will include women receiving adjuvant chemotherapy for breast cancer. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only.

Eligibility criteria:
inclusion criteria: * adjuvant chemotherapy

Keywords: gourmet healthy cooking quality of life adjuvant chemotherapy weight breast cancer